Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream
Study Hypothesis: That the test product will reduce thigh cellulite more that the placebo.
This will be a double-blind, placebo-controlled study involving subjects with distinctive cellulite appearance on both thighs. Subjects will apply test cream to one thigh and placebo to the other, by random allocation, and cellulite appearance will be measured at week 0, 8 and 16. Cellulite photographs will also be assessed by a (study blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Trial to Assess the Efficacy and Safety of a Novel Cellulite Cream in Reducing the Appearance of Cellulite in Human Subjects|
- thigh cellulite appearance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Reduction of cellulite appearance, as assessed by photographs, self-assessment and clinician assessment.
- Uper leg circumference and fat content [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Reduction of upper leg circumference as measured by cm tape measure, and reduction of fat content of upper leg as measured using fat calipers
- Presence/absence of adverse reactions [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Any incidence of an adverse event or events will be recorded in an Adverse Events Diary, and results collated and reported.
|Study Start Date:||June 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: herbal-based cellulite cream
Trial subjects will apply the treatment cream to one thigh and placebo to the other thigh, by random allocation.
Other: Cellulite reduction cream
1/8 tsp cellulite cream will be applied to the thigh twice daily - in the morning and at night, for a period of 16 weeks.
Twenty subjects will be recruited through advertisements in local newspapers. Eligible subjects will be asked to visit the lab, where they will sign an information/consent form and answer a series of questions to determine their eligibility. If eligible, each subject will be asked to have their upper leg cellulite photographed, and thigh circumference will be measured. They will be given two containers of cream, labelled R (for right thigh) and L (for left thigh) which have been pre-weighed in their containers, and they will be instructed on how to apply the cream. They will record their perception of the amount of cellulite on a weekly basis, and they will also record any adverse events. At the two and four-month time-points, they will return to the lab with their diaries and cream. The cream in its container will be weighed to ensure compliance, and the diaries will be examined and returned to the participants. Thighs will again be photographed and circumference measured. At the four-month visit, subjects will return any remaining product for weighing, as well as their diaries for analysis.
Photographs from each subject will be coded and cellulite marks assessed by arranging the photographs chronologically, i.e. timepoint 1, timepoint 2 and timepoint 3. They will also be assessed by a (blinded) trial researcher, who will assess cellulite appearance on a precisely-measured upper leg area in the photographs. The subjects' own perception of cellulite appearance, from their diaries, will be numerically coded, and all three measures will be collated and analysed statistically.
|Nutrasource Diagnostics Inc.|
|Guelph, Ontario, Canada, N1H1Y3|
|Study Director:||Steven Traplin, MD||Nutrasource Diagnostics Inc.|
|Principal Investigator:||Maggie Laidlaw, Ph.D.||Nutrasource Diagnostics Inc.|